Alveolar Ridge AugmentationNCT05892016
Ridge Preservation Using Different Techniques
A study testing Alveolar ridge preservation in people with Alveolar Ridge Augmentation and Connective Tissue, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Soft tissue contour and radiographic evaluation of alveolar ridge preservation using different techniques Background: Following tooth extraction, the alveolar ridge undergoes an inevitable remodeling process which influences future implant therapy or prosthetic rehabilitation in the edentulous area. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation, Connective Tissue, Tooth Extraction
- What is being tested?
- Alveolar ridge preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Feb 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >20 years old
- No contraindications for invasive dental procedures.
- Not pregnant.
- Teeth need to be extracted due to malocclusion or broken teeth.
- Requires dental implant or denture fabrication after tooth extraction.
- Healthy soft tissue (probing bleeding index <20%, plaque index <20%).
Show all 9Show fewer
- At least 2mm of keratinized gingiva on the buccal and lingual sides.
- No need for simultaneous bone augmentation surgery during implant placement.
- Willing to participate in and sign the consent form for this trial.
Who cannot join
- Poor oral hygiene maintenance.
- Uncontrolled periodontal disease.
- Heavy smoker (smokes >20 cigarettes per day).
- Uncontrolled diabetes.
- Alcohol abuse.
- Currently receiving medication treatment affecting wound healing (osteoporosis medication, radiation or chemotherapy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Tissue Contour and Radiographic Evaluation of Ridge Preservation Using Different Techniques
Soft tissue contour and radiographic evaluation of alveolar ridge preservation using different techniques
Background:
Read more
Following tooth extraction, the alveolar ridge undergoes an inevitable remodeling process which influences future implant therapy or prosthetic rehabilitation in the edentulous area. In an attempt to attenuate the loss of hard and soft tissue after tooth loss, alveolar ridge preservation (ARP) immediately after complete tooth extraction could minimize the need for ancillary ridge augmentation or soft tissue grafting. Different techniques and barrier membranes has been proposed to achieve the sealing of extraction socket.
Aim:
To investigate the effect of different techniques and barrier membranes for the soft tissue contour and morphological change of alveolar ridge after ARP
Methods:
The study was designed as a randomized controlled trial and recruited patients, who require ARP for the purpose of implant placement or prosthodontic rehabilitation. After the tooth extraction, patients were randomly allocated to one of the following groups: ridge preservation with a xenogeneic bone substitute and (a) spontaneous healing (control), (b) covered with a free palatal graft, (c) or covered with pedical palatal graft, (d) covered with a collagen membrane, (e) covered with a non-resorbable high-density polytetrafluoroethylene membrane. 2 weeks, 4 weeks, 12 weeks, and 24 weeks following tooth extraction and ARP, clinical profilometric and radiographic evaluations were performed to analyze the change of hard and soft tissue contour. Moreover, and the need for additional guided bone regeneration (GBR) or soft tissue augmentation were assessed prior implants or fixed prosthesis placement.
- Being tested
- Alveolar ridge preservation
- Keywords
- Alveolar Ridge Preservation Connective tissue graft, Tooth extraction, Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservationProcedure or surgery
grafted with bone particle and covered with a subepithelial connective tissue graft
Alveolar ridge preservationProcedure or surgery
grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft
Alveolar ridge preservationProcedure or surgery
grafted with bone particle and covered with a collagen membrane
Alveolar ridge preservationProcedure or surgery
grafted with bone particle and covered with a Cytoplast
| Study group | Role | What they receive |
|---|---|---|
| spontaneous healing | No intervention | No treatment after tooth extraction |
| Bone particle + subepithelial connective tissue graft | Experimental | Alveolar ridge preservation grafted with bone particle and covered with a subepithelial connective tissue graft Receives: Procedure: Alveolar ridge preservation |
| Bone particle + Vascularized interpositional periosteal connective tissue graft | Experimental | Alveolar ridge preservation grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft Receives: Procedure: Alveolar ridge preservation |
| Bone particle + collagen membrane | Experimental | Alveolar ridge preservation grafted with bone particle and covered with a collagen membrane Receives: Procedure: Alveolar ridge preservation |
| Bone particle + Cytoplast | Experimental | Alveolar ridge preservation grafted with bone particle and covered with a Cytoplast. Receives: Procedure: Alveolar ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue alternation
cone-beam computed tomography data and STereoLithography files are superimposed to measure the soft tissue dimensions.
Measured: up to 12 months
Hard tissue alternation
cone-beam computed tomography data and STereoLithography files are superimposed to measure the hard tissue dimensions.
Measured: up to 12 months
Secondary outcomes (2)
Keratinized tissue width changes
Use periodontal probe to measurement.
Measured: up to 12 months
Visual Analogue Scale
Ask the patient to fill out the questionnaire
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start28 Feb 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. spontaneous healing (control) Alveolar ridge preservation grafted with bone particle and 2. covered with a free palatal graft 3. covered with pedical palatal graft 4. covered with a collagen membrane 5. covered with a non-resorbable high-density polytetrafluoroethylene membrane.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-En Sung, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892016
- Sponsor's protocol ID
- A202305015
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Contour and Radiographic Evaluation of Ridge Preservation Using Different Techniques
- ClinicalTrials.gov ID
- NCT05892016
- Acronym / sponsor ID
- A202305015
- Keywords
- Alveolar Ridge Preservation Connective tissue graft, Tooth extraction, Membranes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Soft tissue contour and radiographic evaluation of alveolar ridge preservation using different techniques
Background:
Following tooth extraction, the alveolar ridge undergoes an inevitable remodeling process which influences future implant therapy or prosthetic rehabilitation in the edentulous area. In an attempt to attenuate the loss of hard and soft tissue after tooth loss, alveolar ridge preservation (ARP) immediately after complete tooth extraction could minimize the need for ancillary ridge augmentation or soft tissue grafting. Different techniques and barrier membranes has been proposed to achieve the sealing of extraction socket.
Aim:
To investigate the effect of different techniques and barrier membranes for the soft tissue contour and morphological change of alveolar ridge after ARP
Methods:
The study was designed as a randomized controlled trial and recruited patients, who require ARP for the purpose of implant placement or prosthodontic rehabilitation. After the tooth extraction, patients were randomly allocated to one of the following groups: ridge preservation with a xenogeneic bone substitute and (a) spontaneous healing (control), (b) covered with a free palatal graft, (c) or covered with pedical palatal graft, (d) covered with a collagen membrane, (e) covered with a non-resorbable high-density polytetrafluoroethylene membrane. 2 weeks, 4 weeks, 12 weeks, and 24 weeks following tooth extraction and ARP, clinical profilometric and radiographic evaluations were performed to analyze the change of hard and soft tissue contour. Moreover, and the need for additional guided bone regeneration (GBR) or soft tissue augmentation were assessed prior implants or fixed prosthesis placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- 1. spontaneous healing (control) Alveolar ridge preservation grafted with bone particle and 2. covered with a free palatal graft 3. covered with pedical palatal graft 4. covered with a collagen membrane 5. covered with a non-resorbable high-density polytetrafluoroethylene membrane.
| Arm | Type | Receives |
|---|---|---|
| spontaneous healing | No intervention | –No treatment after tooth extraction |
| Bone particle + subepithelial connective tissue graft | Experimental | Procedure: Alveolar ridge preservationAlveolar ridge preservation grafted with bone particle and covered with a subepithelial connective tissue graft |
| Bone particle + Vascularized interpositional periosteal connective tissue graft | Experimental | Procedure: Alveolar ridge preservationAlveolar ridge preservation grafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft |
| Bone particle + collagen membrane | Experimental | Procedure: Alveolar ridge preservationAlveolar ridge preservation grafted with bone particle and covered with a collagen membrane |
| Bone particle + Cytoplast | Experimental | Procedure: Alveolar ridge preservationAlveolar ridge preservation grafted with bone particle and covered with a Cytoplast. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >20 years old
- No contraindications for invasive dental procedures.
- Not pregnant.
- Teeth need to be extracted due to malocclusion or broken teeth.
- Requires dental implant or denture fabrication after tooth extraction.
Key exclusion criteria (6 listed)
- Poor oral hygiene maintenance.
- Uncontrolled periodontal disease.
- Heavy smoker (smokes >20 cigarettes per day).
- Uncontrolled diabetes.
- Alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar ridge preservationgrafted with bone particle and covered with a subepithelial connective tissue graft | Procedure or surgery | Bone particle + Cytoplast, Bone particle + Vascularized interpositional periosteal connective tissue graft, Bone particle + collagen membrane, Bone particle + subepithelial connective tissue graft |
| Alveolar ridge preservationgrafted with bone particle and covered with vascularized interpositional periosteal connective tissue graft | Procedure or surgery | Bone particle + Cytoplast, Bone particle + Vascularized interpositional periosteal connective tissue graft, Bone particle + collagen membrane, Bone particle + subepithelial connective tissue graft |
| Alveolar ridge preservationgrafted with bone particle and covered with a collagen membrane | Procedure or surgery | Bone particle + Cytoplast, Bone particle + Vascularized interpositional periosteal connective tissue graft, Bone particle + collagen membrane, Bone particle + subepithelial connective tissue graft |
| Alveolar ridge preservationgrafted with bone particle and covered with a Cytoplast | Procedure or surgery | Bone particle + Cytoplast, Bone particle + Vascularized interpositional periosteal connective tissue graft, Bone particle + collagen membrane, Bone particle + subepithelial connective tissue graft |
Primary outcome
Soft tissue alternation
Time frame: up to 12 months
cone-beam computed tomography data and STereoLithography files are superimposed to measure the soft tissue dimensions.
Hard tissue alternation
Time frame: up to 12 months
cone-beam computed tomography data and STereoLithography files are superimposed to measure the hard tissue dimensions.
2 secondary outcomes
Keratinized tissue width changes
Time frame: up to 12 months
Visual Analogue Scale
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Alveolar Ridge Augmentation
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Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
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Alveolar Ridge Augmentation, Bone Substitutes
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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HydroGraft for Mandibular Horizontal Ridge Atrophy Augmentation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation in people with Alveolar Ridge Augmentation and Connective Tissue, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue alternation (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.